Procedure Development Process

The heart of the compliance program is the procedures or systems that connect the legal requirements imposed by TSCA with the actual operations of the business and the jobs of individual employees. The more clearly an employee understands what he or she must do to complete the job in compH-ance with TSCA, the more likely it will be that the employee will not violate 

One way of thinking about how to handle TSCA requirements is depicted in these four different approaches to a compliance integration scheme  

A TSCA compliance program will likely have a mix of these four approaches. 

Using the information developed in the status quo assessment, the company is able to drill down to modify or prepare procedures for actual business processes that are impacted by TSCA requirements. The task is to make 

See Chapter 20, Practice Tools for an explanation of how a procedure might be constructed and a number of model procedures for specific business processes. These models are included 

Is there a formal process in place to determine which safety criteria operations or tasks require procedures (e.g., HAZOPs, risk assessment)  

Do the procedures in existence cover the range of areas or operations expected, such as  

Is there a process in place to consider how the work activities of non-company personnel are managed  

Are the format, type of procedure, and user considered when writing procedures  

Are the types of procedures (e.g., checklists, instructions, flow sheets) appropriate for  

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Workers skilled in doing the job are the first logical resource for a procedure review team. Operators review operating procedures. Maintenance mechanics review maintenance procedures. Laboratory technicians and chemists review laboratory procedures. This promotes employee participation and ownership in the procedure development process. 

FIGURE 4.1 Procedural development process. (Adapted from Marsden, P., in Human Factors in Nuclear Safety, N. Stanton, Ed., Taylor Francis, London, 1996, pp. 99-116.)... 

Marsden (1996) identified three common organizational weaknesses that are involved in procedure system failures. First, the organization involved fails to specify a formal procedure development process, which may lead to incomplete, inaccurate, or even missing procedures. Second, workers fail to follow procedural instructions. Finally, a breakdown occurs in the interrelationship between the procedure system and other operator support aspects such as training and procedure revision. 

Include each affected worker in the safe work procedure development process. 

Checking is performed in accredited laboratories on procedures developed in compliance with stated requirements and approved in the process of testing implementation on CTB 8001-93 or metrological attestation on CTB 8004-93. 

Safety Review. The safety review was perhaps the very first hazard analysis procedure developed. The procedure begins by the preparation of a detailed safety review report. The purpose of this report is to provide the relevant safety information regarding the process or operation. This report is generally prepared by the process engineer. A typical outline for this report follows. 

Enzyme—Heat—Enzyme Process. The enzyme—heat—enzyme (EHE) process was the first industrial enzymatic Hquefaction procedure developed and utilizes a B. subtilis, also referred to as B. amjloliquefaciens, a-amylase for hydrolysis. The enzyme can be used at temperatures up to about 90°C before a significant loss in activity occurs. After an initial hydrolysis step a high temperature heat treatment step is needed to solubilize residual starch present as a fatty acid/amylose complex. The heat treatment inactivates the a-amylase, thus a second addition of enzyme is required to complete the reaction. 

Beta-alumina, mentioned in Section 1.2.2.2, is just the best known and most exploited of this family. They have been developed by intensive research over more than three decades since Yao and Kummer (1967) first reported the remarkably high ionic conductivity of sodium beta-alumina. Many other elements have been used in place of sodium, as well as different crystallographic variants, and various processing procedures developed, until this material is now poised at last to enter battery service in earnest (Sudworth et al. 2000). 

Develop PHA procedure Jones, Process Safety Engineer... 

Control of foulants and corrosion debris Because of the very large volume in these HW systems, there is an obvious reluctance to unnecessarily drain them down because of the development of waterside problems. Therefore, it is important to ensure that before regular operation they are provided with a proper precommission cleaning procedure. This process removes silt, mill-scale, grease, and other foulants, thus enabling passivation and subsequent maintenance inhibition to take place. 

If a manufacturer has modified their own device they can avail of a special 510(k) procedure for declaring substantial equivalence to their existing device, provided that the intended use or the basic technology has not changed. They must apply design controls and risk analysis to the development process, but the advantage is that they can receive a faster review process. 

Comprehensive physicochemical characterization of any raw material is a crucial and multi-phased requirement for the selection and validation of that matter as a constituent of a product or part of the product development process (Morris et al., 1998). Such demand is especially important in the pharmaceutical industry because of the presence of several compounds assembled in a formulation, such as active substances and excipients, which highlights the importance of compatibility among them. Besides, variations in raw materials due to different sources, periods of extraction and various environmental factors may lead to failures in production and/or in the dosage form performance (Morris et al., 1998). Additionally, economic issues are also related to the need for investigating the physicochemical characteristics of raw materials since those features may determine the most adequate and low-cost material for specific procedures and dosage forms. 

The implications of the features of fine chemicals manufacture mentioned above, are, however, not that obvious to all parties taking part in process development. On the one hand, chemical and process engineers are dedicated mainly to the engineering part in process development, often neglecting process chemistry, as this might be erroneously considered less important for a full-scale plant. On the other hand, synthetic chemists often finish their work with laboratory recipes neglecting needs of procedures for process development. The reasons for this approach have been listed by Laird (1989) ... 

Lastly, a laboratory not involved in the development process must validate the method. The independent laboratory validation study, or ruggedness trial, ensures that analysts unfamiliar with the method can successfully perform the method. The method developer should, therefore, strive to make all procedures as straightforward as possible to aid reproducibility of the method. 

Linking TLC with a tandem instrument differs from combining GC or LC with an appropriate spectrometer. Hyphenation of planar chromatographic techniques represents a niche application compared to HPLC-based methods. Due to the nature of the development process in TLC, the combination is often considered as an off-line in situ procedure rather than a truly hyphenated system. True in-line TLC tandem systems are not actually possible, as the TLC separation must be developed before the spots can be monitored. It follows that all TLC tandem instruments operate as either fraction collectors or off-line monitoring devices. Various elaborate plate extraction procedures have been developed. In all cases, TLC serves as a cleanup method. 

A new design situation would start from the grand composite curves of each of the processes on the site and would combine them together to obtain a picture of the overall site utility system12. This is illustrated in Figure 23.27, where two processes have their heat sink and heat source profiles from their grand composite curves combined to obtain a site hot composite curve and a site cold composite curve, using the procedure developed for composite curves in Chapter 16. Wherever there is an overlap in temperature between streams, the heat loads... 

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